Partial Breast Radiotherapy in Low-risk Breast cancer group using a stereotactic MR-guided adaptive approach; a phase II study

Phase 2

Recruiting

Conditions: breast cancer
carcinoma of the breast
10006291

Registration Number: NL-OMON45437

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

- Age > 50 years
- WHO performance score 0-2
- Pathology proven breast cancer with following histology: invasive ductal carcinoma, mucinous, tubular, medullary, colloid cc, and associated LCIS
- Any histologic grade
- Any hormonal receptor status
- T-stage: Tumor size * 3cm (pT1-2)
- N-stage: No positive lymph nodes examined by sentinel lymph node biopsy or axillary lymph node dissection (at least 6 nodes pathologically examined)
- Radical resection of tumor with * 2mm surgical margin free of tumour
- All patients should be able to undergo MRI scans
- Ability to provide written informed consent.
- Ability to perform breath-hold for at least 17 seconds

Exclusion Criteria

- Breast cancer histology of invasive lobular carcinoma, ductal carcinoma in situ sec
- Breast cancer with a multicentric or multifocality character
- An extensive intraductal component in pathology examination
- Lympho-vascular invasion in the pathology examination
- Treatment with neoadjuvant chemotherapy before lumpectomy
- Breast conserving surgery with an oncoplastic breast surgery technique
- Re-excision of tumour in ipsilateral breast
- Open surgical wound or wound infection
- Previous irradiation in the ipsilateral breast
- Contra-indications for MRI

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate early and early-delayed toxicity (defined as the first year<br /><br>following treatment). Toxicity will be monitored at fixed time points using<br /><br>CTCAE, before and during treatment and 3, 9 and 18 months after breast<br /><br>conserving surgery</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Cosmetic outcome and Quality of Life are important secondary outcome measures.<br /><br>Quality of Life will be evaluated using EORTC-QOL questionnaires (EORTC-QoL C30<br /><br>& Breast Cancer module QLQ BR23).<br /><br>Cosmetic outcome will be evaluated using three previously used methods in VUmc<br /><br>consisting of a panel, BCCT.core-software and patient self-evaluation.<br /><br>Offline dosimetric comparison between this new MR-guided adaptive approach in<br /><br>breath-hold and current techniques described in recent literature</p><br>